Mirum Pharmaceuticals, Inc. MIRM incurred a loss of 30 cents per share in third-quarter 2024, much narrower than the Zacks Consensus Estimate of a loss of 45 cents. The company had reported a loss of 57 cents per share in the year-ago quarter.

Revenues in the third quarter totaled $90.3 million, up 89% year over year. The figure also beat the Zacks Consensus Estimate of $82 million. The top line comprised Livmarli (maralixibat) sales, newly acquired Cholbam and Chenodal sales, and minimal license and other revenues.

Mirum acquired Travere Therapeutics’ bile acid products in August 2023, which added the latter’s Cholbam capsules and Chenodal tablets to its portfolio of commercialized drugs.

Shares of Mirum were up in pre-market trading on Nov. 12 owing to better-than-expected results and increased guidance for 2024. The stock has rallied 40.9% so far this year against the industry’s decline of 1.2%.

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More on MIRM's Q3 Results

Livmarli’s net product sales were $59.1 million in the third quarter, reflecting an increase of almost 52.7% year over year.

Net product sales of newly acquired Cholbam and Chenodal were $31.2 million.

License and other revenues were $0.07 million in the reported quarter. The company did not record any such revenues in the year-ago quarter.

Research and development expenses increased 21.5% year over year to $31.7 million.

Selling, general and administrative expenses totaled $50.5 million, up almost 38.3% from the year-ago quarter’s level.

As of Sept. 30, 2024, Mirum had cash, cash equivalents and marketable securities worth $293.8 million compared with $295.4 million as of June 30, 2024.

2024 Guidance

Mirum increased its financial guidance for 2024. The company now expects revenues in the range of $330-$335 million compared with the earlier projection of $310-$320 million.

MIRM's Recent Updates

Along with the earnings release, the company announced that it has initiated the phase III EXPAND study, which is a label expansion opportunity for Livmarli in additional settings of cholestatic pruritus.

The European Commission approved Livmarli oral solution for the treatment of progressive familial intrahepatic cholestasis (PFIC) in patients aged three months and above in July 2024. PFIC is a rare genetic disorder that causes liver failure.

The FDA approved a label expansion for Livmarli oral solution to include the treatment of cholestatic pruritus in patients aged five years and older with PFIC in March. Livmarli is also approved for treating cholestatic pruritus in PFIC patients aged 12 months and above in the United States.

In June 2024, the new drug application for chenodiol for treating cerebrotendinous xanthomatosis patients was filed in the United States. The FDA has set a target action date of Dec. 28, 2024.

Mirum’s pipeline candidate, volixibat, is currently being evaluated in two phase IIb studies for treating patients with primary biliary cholangitis (the VANTAGE study) and primary sclerosing cholangitis (the VISTAS study).

Last month, the FDA granted a Breakthrough Therapy designation to volixibat as a potential treatment for cholestatic pruritus in patients with primary biliary cholangitis.

Along with the earnings release, Mirum announced that it has in-licensed a PDE4D inhibitor, MRM-3379, for treating Fragile X syndrome, a rare neurocognitive disorder. A phase II study on the same is expected to begin in 2025.

MIRM's Zacks Rank & Key Picks

Mirum currently carries a Zacks Rank #4 (Sell).

Some better-ranked stocks from the biotech sector are Immunocore Holdings plc IMCR, ANI Pharmaceuticals, Inc. ANIP and Castle Biosciences, Inc. CSTL, each carrying a Zacks Rank #1 (Strong Buy) at present. You can see the complete list of today’s Zacks #1 Rank stocks here.

In the past 60 days, estimates for Immunocore’s 2024 loss per share have narrowed from $1.67 to 96 cents. Loss per share estimates for 2025 have narrowed from $2.35 to $1.70 during the same time. Year to date, shares of IMCR have declined 49.3%.

IMCR’s earnings beat estimates in two of the trailing four quarters while missing the same on the remaining two occasions, the average surprise being 25.57%.

In the past 60 days, estimates for ANI Pharmaceuticals’ 2024 earnings per share have moved up from $4.59 to $4.71. Earnings per share estimates for 2025 have improved from $4.82 to $5.65 during the same time. Year to date, shares of ANIP have increased 11.9%.

ANIP’s earnings beat estimates in each of the trailing four quarters, the average surprise being 20.27%.

In the past 60 days, estimates for Castle Biosciences’ 2024 loss per share have narrowed from 58 cents to 8 cents. Loss per share estimates for 2025 have narrowed from $2.13 to $1.88 during the same time. Year to date, shares of CSTL have surged 56.5%.

CSTL’s earnings beat estimates in each of the trailing four quarters, the average surprise being 172.72%.

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